U.S. Pat. No. 7,732,410, discloses compositions and methods for the reduction of atherosclerotic plaques. The patent is based on the hypothesis that the presence of mycoplasma and one or more other microorganisms promote the formation of atheroma. The compositions and methods of the patent may also be used to reduce the total level of cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol. In a manner not limited of the invention, the composition comprises a protein capable of removing sialic acid residues, as a neuraminidase enzyme and/or a trans-sialidasa enzyme, a metal chelator, preferably pyrrolidine dithiocarbamate (PDTC), together with one or more purified extracts of plants. One purified plant extract may be derived from a plant selected from the group consisting of Allium Sativum (garlic), Ginkgo Biloba, tomato, orchids of the genus Cymbidium and Dendrobium, for example, Cymbidium ssp, Dendrobium Nobile Moschatum, and Dendrobium; guava, ginseng, for example, Pfaffia Paniculata (Brazilian ginseng), Zingiber Officinale (ginger); and tobacco. The purified extract includes particles that contain DNA or RNA, such as archaea or a nano-archaea. To clarify, this patent cites a product that includes a metal chelator and other products that include plant extracts. It is important to highlight that the patent did not mention a composition with chemical interaction between the extracts of Gentiana lutea and Hippocratea excelsa to provide novel synergistic effects.
In addition, it is important to highlight that the chelating agent may cause important damage to artery walls, which represents a risk in the use of these products. In addition, the product mentioned in this patent is not able to regulate the behavior of the immune cells involved in the pro-inflammatory process and the genesis of foam cells and thus in the formation of atheroma plaque.
So, a person might think that a chelating agent may ‘reduce’ the atheroma plaque but would not have a preventive effect on the formation of atheroma plaque nor in the increased pre-existing plaque, or in the formation of new atheroma plaques in the blood system. Furthermore, as it is known, that a chelator can damage the arteries and may not be from repeated use, without causing arterial damage or even an arterial thrombosis. On the other hand, U.S. Pat. No. 6,989,165, discloses to a synergistic pharmaceutical composition useful for the treatment of Hyperlipidemia. The composition comprises plant extracts such as Kurroo Gentian of concentration between 2 to 5% by weight, Murraya Koenigii in concentration ranging from 8 to 15% by weight, Allium Sativum in concentration ranging between 2 and 4% by weight, Zingiber Officinalis in concentration ranging between 2 to 5% by weight, Amorphophallus Campanulatus in concentration between 1 and 10% by weight, and pharmaceutically acceptable additives. In addition, the patent discloses a process for the preparation of such synergistic pharmaceutical composition and also for the use of the composition for the treatment of Hyperlipidemia, atherosclerosis, and obesity.
More particularly, the U.S. Pat. No. 6,989,165 discloses a compound that includes different plant species, including among them the genus Kurroo Gentian. This patent is focused primarily in the lipids metabolism and is available to provide management of Hyperlipidemia, atherosclerosis, and obesity, but it is not clearly defined whether these compounds will work on the pro-inflammatory state, pro-thrombotic, or whether the composition is able to prevent the formation of plaque or can break the plaque. In addition, the patent does not mention the synergistic interaction of components to generate new healing compositions.
The U.S. Patent Publication No. 20100202980, discloses herb based compositions comprising at least one Urtica species or an extract of it, at least one Artemisia specie, or an extract of it, and an extract of at least one Morus specie, wherein the extract is prepared from leaves of Morus and includes a Morus latex. Also discloses methods for the preparation of these compositions, their use in the treatment and/or prevention of diabetes, hypertriglyceridemia, and related conditions. The patent discloses that conditions associated with Diabetes II include atherosclerosis and indicated the use of Gentiana Olivieri as methods of treatment of patients who suffer from these conditions.
US Patent Application Publication No. 20100202980 discloses the combination of different plant species, one of them being the Gentiana genus, but a different species (Olivieri) and focuses on the metabolic type management of the conditions related to diabetes and hypertriglyceridemia. As in the earlier mentioned patents, this patent does not define its ability to specifically influence the pro-thrombotic status, pro-inflammatory, nor indicates that the combination is effective in the prevention of plaque formation, or that it is able to disintegrate the plaque, as is the case with the present invention which is able to act at all these levels.
U.S. Patent Application Publication No. 20060189512, discloses compositions containing a therapeutically effective amount of extract of phlorizin for the glucose modification in the blood and insulin, facilitate weight loss, prevent weight gain, and provide beneficial effects on the aging process. The patent also discloses a method of treatment of animals with extract of phlorizin, which includes compositions for the treatment of the above-mentioned conditions. These compositions include extracts of Gentiana Olivieri or Hippocratea Excelsa. Thus, the resulting effects arising from this document again relate to metabolic effects (diabetes management and obesity) and not on the effects on the pathogenic mechanisms of atherosclerosis.
U.S. Pat. No. 7,074,435, discloses a pharmaceutical composition comprising essentially of a base of an extract from herbs such as: Chaenomelis Fructus, Radix Achyranthis, Acanthopanax, Radix Phlomidis, Radix Gantianae Clematidis Radix, and includes also an extract from herbs selected from the group consisting of: Angelicae Radix, Rhizoma Cnidii Gastrodiae Rhizoma, safflower, Cinnamomi Cortex, tear of Job, Aurantii Nobilis PericapiumRadix Ledebouriellae, Lonicera Japonica, Caulis Akebiae, Caragana Chamlagu, licorice root, Incisum Notopterygium, Persicae Semen, Ulmoides Eucommia, Atractylodes Rhizoma, Torilis Japonica, Gentiana radix Gentiana macrophylla, Gentiana maschurica and Gentiana lutea, in combination with other plant extracts for the prevention and treatment of inflammatory diseases and arthritis; which are used for the prevention and treatment of arthritic diseases. The invention also refers to methods for using the previous species extracts and compositions that use them as potent anti-inflammatory and anti-arthritic agents. In this patent document, the disclosed combination is apparently related to the curative management of inflammatory joint diseases, and does not specify to have antiateromatosos effects, antithrombotic effects, nor the obstructive atherosclerotic disease control, in any sense.
Finally, U.S. Pat. No. 7,759,393, discloses a composition containing 1,3-propanediol and an extraction product; 1,3-propanediol in a biological origin composition. The patent also discloses the extraction processes for the extract of a source. These processes include using an ester of 1,3-propanediol and mix the ester 1,3-propanediol with the source. This serves to obtain the extract from the source in the ester. The processes also include separate ester source and the extract. Also discloses compositions containing an ester of 1,3-propanediol and a product of the extraction. In these compositions, the ester may have at least 3% of bio-based carbon. However, this patent does not specify which function or particular effect these compounds may have for the treatment and/or prevention of obstructive atherosclerotic diseases or its complications.
As can be seen, there is currently no development of a similar compound in which the compounds of two plant species synergistically chemically interact in order to obtain a third group of substances that differ from which originated, but even less with the objective of creating a specific treatment for a disease that affects the artery walls.
Thus, it is clear that there have been attempts to attack arterial disease using extracts of plant species, however, these attempts used isolated extracts and never searched for the synthesis of new products created from the combination of extracts of different species. In addition, it has not been researched that certain specific substances exert a synergy effect among them to achieve its unexpected therapeutic effect as it arises in the present invention.
It is important to mention also that in the field of the Chemo pharmacy it includes compounds such as the following to address the problem:
Statins: Although known to reduce hepatic LDL synthesis by inhibition of the HMG CoA reductase, these compounds are hepatotoxic and damage the muscle tissue, in addition they help to reduce the atheromatous plaque thickness up to 5% only after 18 months of treatment and their cost is rather high.
Ezetimibe: This compound inhibits the absorption of cholesterol in the intestine but does not contribute to directly reduce the plaque, in addition it has adverse effects when used concomitantly with statins and has a very high cost.
Fibrates: The fibrates activate the protein lipase that degrades the VLDL and chylomicrons in the liver, releasing its lipidieos components and directing them to the synthesis of HDL. However, they also are hepatotoxic and have a high cost.
Niacin: This compound decreases the LVDL in the liver, lowering the blood triglycerides, but it introduces intolerable side effects to the body such as intense itching, skin rash, etc. They can also generate gastric ulcer and liver damage. Its new forms of presentation for delayed-release are very expensive.
Aspirin: It is a known inhibitor for the plaque aggregation, but it can cause ulcers and bleeding of the digestive tract in people susceptible and/or with long periods of administration.
Clopidogrel: Like many other compounds intended to treat plaque aggregation, this compound is very expensive and produces side effects.
All these drugs, independently and/or combined in different treatment schemes, are used to treat different factors and mechanisms that generate arterial disease, however none of them alone or even combined, significantly reversed the arteries occlusion as proposed by the present invention, due to the synergistic effect that is produced from the blend of herb extracts which results in the arterial repermeabilisations, with non-toxic collateral and side effects, and a very low cost.
As already mentioned, the statins, ezetimibe, fibrates, niacin, aspirin and clopidogrel, in different combinations and treatment schemes, act over some of the mechanisms of the atherosclerotic disease, but not even all of these drugs used together, manage to disintegrate the atheroma plaques and significantly recover the original caliber of the arteries.
In this sense the literature reports that with these treatments and diet, the arteries are repermeabilised up to 5% after 18 months of treatment.
On the other hand, it is relevant to discuss the components that until now have been isolated separately from the two herbal species that are being exposed (G. lutea and H. excelsa) and the therapeutic effects for which have been used in traditional form and from long ago.
In the case of Gentiana lutea, the bibliography reports the following compounds: genciopicrosido, amarogenciosido, Eswerciamarosido, pigments of xanthones, denticina, genciosido, disaccharides (sucrose, gencianosa, genciobiosa), phytosterols, pectin, essential oil.
It is very important to clarify that these compounds have been used traditionally to stimulate digestive secretions, in dyspepsia, fullness, and flatulence. These compounds may present antimicrobial effects in some cases. Never derived from this plant have been proposed in isolated form to treat the pathogenic mechanisms of atherosclerosis.
It is appropriate to comment here that in the crystallization of the extracts of G. lutea with identification purposes, yellow crystals are obtained.
The case of Hippocratea excelsa, are disclosed below the components that have been isolated by alcoholic extraction. CANOPHYLLOL, CANOFILAL, CANOFILICO, FRIEDELINA, CELASTROL, EXCELSITA acid, PISTIMERINA, TINGENONE, B-CITOSTEROL, HIPOCRATEINA I and II, EMARGINATINA, MAYTEINA, HIPOCRATEINA III.
For the clinical use that has been proposed for the extracts of hippocratea excelsa are: anti-inflammatory action, anti-arthritic, anti-carcinogenic, antimicrobial and fungicidal. As in the case of the Gentiana lutea, the H. excelsa extracts in isolation form has never been proposed for the management of atherosclerosis and never was their use suggested to be in synergistic chemical interaction together with g. lutea. 
It is important to mention here that the compounds obtained from the combination of both herbal species are predominantly: tannins, flavonoids, terpenes, coumarins and others, which in the bibliographic have not been reported as extracts from these plants, but treated separately.
Finally, it is important to note that patients who, by the extent of damage to their arteries, require invasive or surgical procedures to restore the circulation of their arteries, are subjected to such treatments that are feasible and effective are also extremely risky or costly, being any convenient time preventing these problems using the composition proposed in this invention being an alternative non-invasive, low-cost, clinically tested and made from herbal compounds.
Emphasizing once more is the fact that there is currently no development of a synergistic composition in which chemically interacting compounds from two plant species or herbal, with the purpose of obtaining a polypharmaceutical with new properties and at the same time the composition be very effective when used in the specific treatment for a disease that affects the walls of the arteries.